My Experience
Co-founder and Board Member
- Connecting Regulatory Affairs Professionals
- Facilitating Regulatory Exchange
Associate Lecturer
- Clinical Evaluation
- State-of-the-Art Evaluation
Founder & Owner
- Clinical Evaluation Consulting
- PMS/PMCF Consulting
- Clinical Development Planning
- Regulatory Affairs Consulting
- Clinical Data generation
Freelance Consultant – Projects
- Clinical Evaluation process for external service provider
- Clinical Evaluation process for CRO
- Regulatory Strategy and Clinical Evaluation according to MEDDEV 2.7.1 for a resorbable medical device
- Regulatory Strategy for coated stent
- Risk Management consultant for manufacturer of dialysis products (leading global harmonization of Risk Management process with interface to
- Clinical Evaluation process)
- Regulatory Strategy for pharmaceutical application device
- Risk Management for HF surgical device
- Interim Risk Manager and team lead (Disposables for heart-lung machines; Update of 35 risk management files; Implementation of Risk Management tool)
- Clinical Evaluations according to MEDDEV 2.7.1 for orthopaedic implants
- Biological Safety Evaluation according to DIN EN ISO 10993-1 for orthopaedic implants
- Regulatory Strategy for surgical instruments for orthopeadic implants
- Regulatory Strategy and complete Technical Documentation for CE mark for mobile organizational units
Head of Regulatory Affairs
- Responsible for all CE-marked medical devices (non-active) of SFM
- Responsible regulatory affairs contact person for OEM clients from medical device and pharmaceutical industry
- Responsible for update of all technical documentations
- Process optimization for risk management
- Implementation of clinical evaluation and usability engineering processes, as well as standardized procedures for preclinical testing
- In-house training of colleagues in regulatory affairs topics
- Strongly involved in implementation of document management system for the whole company
- Demarcation between drugs and medical devices – Presentation at University of Applied Sciences in Ansbach, Germany
- RAPS Online University student in dual course for pharmaceuticals, medical devices & combination products (US and EU regulations)
- Speaker at conferences and seminars on Regulatory & Clinical Affairs (e.g. Forum Institut, BVMed)
- Speaker at Medica/Compamed 2013 on Safety Protection Devices
- Member of BVMed working team Regulatory and Political Affairs
- Member of DIN working groups for quality management and risk management standard
Functional Head Non-active medical devices and Clinical Affairs
- Responsible Manager for Clinical and Preclinical Affairs with a team of three employees and more than 15 freelance partners
- Responsible for Clinical Evaluations according to MEDDEV 2.7.1 (Rev.3) for more than 100 different products of more than 50 different manufacturers
- Clinical Evaluation and Drug Delivery Devices – In-house training and training in cooperation with Forum Institut and APV
- Planning of Clinical Investigations according to EN ISO 14155 in cooperation with freelance partners
- Biological Evaluations according to DIN EN ISO 10993-1 and coordination of tests with external labs
- Technical Documentation, responsible for compilation of 20 technical files for joint implants (higher classification)
- Expert statements concerning demarcation questions for medical devices and medicinal products
- Summary Technical Documentation according to GHTF guidance
- Review of 510(k) for active medical device
- Support for reimbursement questions in Germany (G-BA and Hilfsmittelverzeichnis)
- ISO 13485 Training, including QMB, internal auditor and third party auditor
- Responsible for sales and acquisition for clinical evaluations and related topics
- Strongly involved in business development of Yes Medical and interface to Yes Pharmaceutical Development Services (mother company)
- Partly responsible for content of company website and for online marketing of the site
- Technical Documentation, compilation of 35 technical files for class I, IIa and IIb medical devices
- Risk Analysis, Risk Management, DIN EN ISO 14971
- Project management and coordination of a project including 15 team members and including communication with external partners on behalf of the client
Development Engineer
- Product development: remittance work and in-house development
- Patent and literature research, preliminary tests and conceptional development, product design and prototyping, support until serial production
- Product example: Drug transfer systems, PEEK Cage, Liquor-Drainage System, Port-catheter system including port needle, Vertebroplasty syringe, Retractor system for minimal invasive surgery
- Risk analysis and risk assessment, quality management for medical device manufacturer according to DIN EN ISO 13485
- Clinical Evaluation including literature search and assessment of publications according to evidence based medicine
My Career
2002
Degree - University of Applied Sciences
2003
Development Engineer
2007
Functional Head
2012
Head of Regulatory Affairs
2014
Freelance Regulatory Affairs Expert
2018
Founder & Owner
My Skills
Clinical Evaluation
Technical File
Risk Management
Regulatory Strategy
Quality Management
Bio
Usability
My Values
compliant Clinical Evaluation Reports
MDR Implementation & Readiness
efficient Risk Management
optimized Requlatory Strategy
proactive Post-Market Surveillance
living Quality Management
My Availability
MDR Implementation projects
upon request
Clinical Evaluation Reports
upon request
Trainings/Speaker
upon request
All other projects
upon request